Abstract
BackgroundAlthough effective results of many studies support the use of spinal cord stimulation in chronic pain patients, no randomized controlled trial has been undertaken in China to date. CITRIP is a multicenter, prospective, randomized, withdrawal study designed to evaluate the clinical effectiveness and safety of spinal cord stimulation plus remote programming management in patients with intractable trunk or limb pain.MethodParticipants will be recruited in approximately 10 centers across China. Eligible participants with intractable trunk or limb and an average visual analog scale (VAS) score ≥ 5 will undergo a spinal cord stimulation test. Participants with VAS score reduction ≥ 50% could move forward to receive implantation of an implanted pulse generator. In the withdrawal period at 3-month follow-up visit, participants randomized to the experimental group (EG) will undergo continuous stimulation while ceasing the stimulation in the control group (CG). The outcome assessment will occur at baseline and at 1, 3 (pre- and post-randomization), and 6 months. The primary outcome is the difference of maximal VAS score between EG and CG in the withdrawal period compared with baseline before the withdrawal period. Additional outcomes include VAS score change at 1-, 3-, and 6-month follow-ups; responder rate (VAS score improving by 50%); achievement rate of a desirable pain state (VAS score ≤ 4); awake times during sleep; Beck Depression Inventory for depression evaluation; short-form 36 for quality of life evaluation; drug usage; and satisfaction rating of the device. Adverse events will be collected. The primary analysis will follow the intention-to-treat principle.DiscussionThe CITRIP study seeks to evaluate the effectiveness and safety of a randomized withdrawal trial of spinal cord stimulation for patients with intractable trunk or limb pain.Trial registrationClinicalTrials.gov NCT03858790. Registered on March 1, 2019, retrospectively registered
Highlights
Effective results of many studies support the use of spinal cord stimulation in chronic pain patients, no randomized controlled trial has been undertaken in China to date
Some systematic reviews suggested that spinal cord stimulation (SCS) has strong evidence for treating axial back/lumbar radiculopathy, neuralgia, and complex regional pain syndrome with long-term costeffectiveness when compared with alternative treatment modalities [7, 8]
The past five decades have witnessed the development of SCS from a conception to a well-established therapy, named as “the last resort therapy” for chronic intractable pain
Summary
The past five decades have witnessed the development of SCS from a conception to a well-established therapy, named as “the last resort therapy” for chronic intractable pain. Numerous studies have demonstrated that SCS is clinically effective for the chronic intractable pain induced by failed back surgery syndrome, complex regional pain syndrome, periphery ischemic pain, refractory angina pectoris, and many other diseases [3,4,5,6, 13]. We propose this first SCS trial in China using a randomized withdrawal design demonstrating that the SCS is well tolerated and effective for the management of chronic intractable pain. The Gross Domestic Product (GDP) per capita in 2018 is $9376.97, one sixth of US’s For this development level, post-operative programming is still a big burden for the neuromodulation patients.
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